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EC number: 206-017-1 | CAS number: 288-13-1
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Skin: Rabbit. Irritant. Standardized test protocol. Reliability = 2
Eye: Rabbit. Seriously eye damaging. Standardized test protocol. Reliability = 2
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Acceptable, well documented publication/ study report which meets basic scientific principles.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- To determine the irritation potential of the test substance, rabbits were exposed dermally to the test substance for 24 hours under occlusive conditions.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Breeder: W. Ostrop / Meerbusch
The animals were caged single and had "mümmel z" (ssniff / Soest) for diet and water ad libitum.
Temperature 16 - 18 °C, Humidity 40 %
12 h light/12 h dark cycle
Acclimatization period 7 - 14 d. - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Amount / concentration applied:
- 500 mg in water
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 8 d
- Number of animals:
- 3
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 2.8
- Max. score:
- 4
- Reversibility:
- other: animals died
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- other: animals died
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 5.8
- Irritant / corrosive response data:
- The test substance caused strong erythema and edema after a 24 h treatment. The irritation index of 5.8 gives indication that the substance is strongly irritating to the skin.
- Other effects:
- 72 h after application all animals were dead because of hematuria, splenic congestion, bloody intestine lymph nodes, petechia at the thymus, soaked liver - alltogether, a strong substance-related toxicity was found.
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The test substacne caused strong erythema and edema after a 24 h treatment. The irritation index was 5.8.
- Executive summary:
To determine the irritation potential of the test substance, rabbits were exposed dermally to the test substance for 24 hours under occlusive conditions. The test substance caused strong erythema and edema after a 24 h treatment. The irritation index of 5.8 gives indication that the substance is strongly irritating to the skin.
Reference
Readings |
Animal |
|||
Erythema |
Edema |
Additional findings |
||
24 h |
1 |
4 |
3 |
|
2 |
2 |
3 |
||
3 |
2 |
2 |
||
72 h |
1 |
4 |
3 |
|
2 |
2 |
2 |
||
3 |
3 |
1 |
||
8 d |
1 |
dead |
dead |
|
2 |
dead |
dead |
||
3 |
dead |
dead |
||
Mean 24, 48, 72 h |
1 |
4 |
3 |
|
2 |
2 |
2.5 |
||
3 |
2.5 |
1.5 |
||
Mean 24, 48, 72 h |
1-3 |
2.8 |
2.3 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- according to guideline
- Guideline:
- other: Code of Federal Regulations, Title 16, Section 1500.42
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Breeder: W. Ostrop / Meerbusch
The animals were caged single and had "mümmel z" (ssniff / Soest) diet and water ad libitum.
Temperature 16 - 18°C, Humidity 40 %
12 h Light/12 h Dark-Cycle
Acclimatization period 7 - 14 d - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal
- Amount / concentration applied:
- 100 µL
- Duration of treatment / exposure:
- single treatment
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not rinsed
SCORING SYSTEM: OECD/Draize score - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 8 days
- Remarks on result:
- other: see table in IUCLID for details
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks:
- within 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritant / corrosive response data:
- The test substance caused a light corneal opacity, iritis, strong erythema and edema of the conjunctivae and increased lacrimation. The clear irritation effects at the eye were only partly reversible within 8 days.
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Regarding the results of the study, the test substance caused irreversible damage to the eyes.
- Executive summary:
The eye irritation potential of the test substance was conducted following methods reported in Code of Federal Regulations, Title 16, Section 1500.42. The test substance (100 µL) was instilled into one eye of 3 rabbits. The other untreated eye served as control. Effects were recorded for up to 8 days after administration. The test substance caused a light corneal opacity, iritis, strong erythema and edema of the conjunctivae and increased lacrimation. The test substance clear irritation effects at the eye were only partly reversible within 8 days.
Reference
Readings |
Animal |
Cornea |
Iris |
Conjunctiva |
Additional findings |
|||
op |
ar |
red |
ch |
di |
||||
24 h |
1 |
1 |
4 |
1 |
3 |
4 |
3 |
|
2 |
1 |
4 |
1 |
3 |
4 |
3 |
||
3 |
1 |
4 |
1 |
3 |
4 |
3 |
||
48 h |
1 |
1 |
4 |
1 |
3 |
4 |
3 |
|
2 |
1 |
4 |
1 |
3 |
4 |
3 |
||
3 |
1 |
4 |
1 |
3 |
4 |
3 |
||
72 h |
1 |
1 |
4 |
1 |
3 |
4 |
3 |
|
2 |
1 |
4 |
1 |
3 |
4 |
3 |
||
3 |
1 |
4 |
1 |
3 |
4 |
3 |
||
8 d |
1 |
1 |
2 |
1 |
2 |
2 |
3 |
|
2 |
1 |
2 |
1 |
3 |
2 |
3 |
||
3 |
1 |
4 |
1 |
3 |
4 |
3 |
||
Mean 24 -72 h |
1 |
1 |
4 |
1 |
3 |
4 |
3 |
|
2 |
1 |
4 |
1 |
3 |
4 |
3 |
||
3 |
1 |
4 |
1 |
3 |
4 |
3 |
||
Mean 24-72 h |
1-3 |
1 |
4 |
1 |
3 |
4 |
3 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In a Draize test following a standard test protocol, shaved skin areas of three New Zealand White rabbits received 500 mg of the test substance (purity unknown) in water for 24 hours. During the relevant reading period of 24 -72 hours, the mean erythema score was 2.8 and the mean edema score was 2.3 (scoring system according to the OECD/Draize scheme). The observation period was finished after the 72 hour reading since all animals are were dead because of haematuria, splenic congestion, bloody intestine lymph nodes, petechia at the thymus, soaked liver – all together a strong substance-related toxicity. Under the conditions of the test, the test substance was considered as irritant to the skin.
In a study following Fed. Reg. protocol, 100 mg of the unchanged test substance (purity unknown) was administered to the eyes of three New Zealand White rabbits; the eyes were not rinsed. During the relevant reading period 24 -72 hours, the overall scores for corneal opacity, iritis, conjunctivae redness and chemosis were 1.0, 1.0, 3.0 and 4.0, respectively (according to the OECD/Draize scheme). Discharge was also observed (mean score 3.0). Effects were only partly reversible during the observation period; therefore, the test substance was considered as causing serious damage to the eyes.
Justification for classification or non-classification
Based on effects observed in the skin and eye irritation studies, the test substance is classified for skin and eye irritation as Cat 2 (H315: Causes skin irritation) and Cat 1 (H318: Causes serious eye damage), respectively according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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